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NCT01545141 · ClinicalTrials.gov registry record · Phase 1
Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01545141: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT01545141 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01545141, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors. The results will allow the investigators to determine the "preferred" combination for subsequent extended studies.
Primary Outcome
This will be assessed by the increase in the total number of tumor-infiltrating CD8+ T cells in the resected, recurrent CRC lesions (measured as the ratio between the CD8 mRNA message and the expression of the housekeeping gene HPRT), comparing Arm A and Arm B.
Interventions
- DRUG Chemokin Modulatory Regimen (5 MU/m2)
- DRUG Chemokin Modulatory Regimen (10 MU/m2)
- DRUG Chemokin Modulatory Regimen (20 MU/m2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-04-08 |
| Phase | Phase 1 |
Why NCT01545141 stopped before completion
NCT01545141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Chemokin Modulatory Regimen (5 MU/m2) is the first listed.
NCT01545141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01545141 about?
NCT01545141 is a clinical study titled "Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer". Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors. The results will allow the investigators to determine the "preferred" combination...
What is the current status of trial NCT01545141?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-10. Estimated completion is 2017-04-08.
What interventions are being tested in trial NCT01545141?
The interventions under investigation include: Chemokin Modulatory Regimen (5 MU/m2) (DRUG), Chemokin Modulatory Regimen (10 MU/m2) (DRUG), Chemokin Modulatory Regimen (20 MU/m2) (DRUG).
Who is sponsoring clinical trial NCT01545141?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01545141's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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